Posted by Michael Wonder on 07 Nov 2021
Ocugen announces submission of emergency use authorisation request to the US FDA for investigational COVID-19 vaccine Covaxin (BBV152) for children ages 2-18 years
5 November 2021 - Paediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralising antibody response as seen in a large adult Phase 3 clinical trial conducted in India.
Ocugen announced today that it has submitted a request to the U.S. FDA for emergency use authorisation of Ocugen’s COVID-19 vaccine candidate BBV152, known as Covaxin outside of the U.S., for paediatric use.
